Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic Sclerosis

Proton pump inhibitor (PPI) twice daily dosing regimen-a standard dose therapy for gastroesophageal reflux disease (GERD)-is an effective therapy for uncomplicated GERD in systemic sclerosis (SSc) but there is no data of response rate of standard dose of PPI and predictors of PPI-partial response (PPI-PR) GERD in SSc.Objectives of the study were to determine the prevalence of omeprazole partial response GERD in SSc and to define the predictors of PPI-PR GERD in SSc. Adult SSc patients having GERD were treated with omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks. Severity of symptom-grading by visual analogue scale (VAS) and frequency of symptoms by frequency scale for symptoms of GERD (FSSG) were assessed at baseline and 4 weeks after treatment. PPI-PR GERD was defined by less than 50% improvement in VAS of severity of symptom and acid reflux score by FSSG after treatment compare to baseline.

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux; Systemic Sclerosis; Proton Pubm Inhibitor
• Intervention / Treatment: Drug: Omeprazole 20mg

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. SSc patients aged between 18 and 65 years.
2. Clinically diagnosed as GERD
3. Must not receive any PPI or prokinetic drug within 2 weeks before baseline evaluation

Exclusion Criteria:

1. Pregnancy or lactation
2. Previous history of gastroesophageal surgery or endoscopic therapy due to severe erosive esophagitis
3. Present of Barrett's esophagus
4. Bedridden and confined to no self-care
5. Evidence of active malignant disease
6. Present of uncontrolled or severe medical problems such as asthma, angina, hepatic or renal diseases
7. Present of active infection that needs systemic antibiotic
8. Allergic history of omeprazole
9. Receiving prohibit co-medications that may have drug interaction or attenuate GERD symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: proton pump inhibitor; omeprazole 20 mg twice daily	Drug: Omeprazole 20mg; omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changing severity of heart burn of SSc related GERD evaluated by visual analogue score (VAS) Changing Severity of Heart Burn of SSc Evaluated by Visual Analogue Score (VAS)	VAS scale 0-100 was applied for an outcome measurement of the severity of heart burn. The VAS scale 0 was no symptoms of heart burn and scale 100 was a maximum symptom of heart burn. The changing of the severity of heart burn was the changing of VAS before and after treatment. PPI-PR GERD is defined when the changing of severity of heart burn is improvement less than 50% compare to baseline.	4 weeks
Changing of Frequency of Symptoms in SSc related GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG)	Unit scale 0-48 was applied for an outcome measurement of the frequency of symptoms. The unit scale 0 was no symptom and scale 48 was usual symptom of GERD. The changing of the frequency of symptoms was the changing of the unit scale before and after treatment. PPI-PR GERD is defined when the changing of frequency of symptom in SSc related GERD evaluated by FSSG is improvement less than 50% compare to baseline.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participant with diffuse cutaneous SSc (dcSSc) subset between the patient who response to omeprazole and partial response to omeprazole,	The number of dcSSc subset in the patient who response to omeprazole and partial response to omeprazole, DcSSc is defined as yes or no when the patient has skin tightness includes trunk and both extremities and not include trunk and extremities, respectively.	4 weeks
The proportion of participant with esophageal dysphagia between the patient who response to omeprazole and partial response to omeprazole,	The number of dysphagia in the patients who response to omeprazole and partial response to omeprazole. Esophageal dysphagia is defined as yes or no when the patients has dysphagia and no dysphagia symptom, respectively.	4 weeks
The proportion of participant with female gender between the patient who response to omeprazole and partial response to omeprazole	The number of female gender in the patients who response to omeprazole and partial response to omeprazole. Female gender is defined as yes or no when the patient is female and male, respectively.	4 weeks
The proportion of participant with age>60 years between the patient who response to omeprazole and partial response to omeprazole	The number of age>60 years in the patients who response to omeprazole and partial response to omeprazole. Age>60 is defined as yes or no when the patient has age>60 and equal or less than 60 years, respectively.	4 weeks
The proportion of participant with modified Rodnan skin score (mRSS)>20 between the patient who response to omeprazole and partial response to omeprazole	The number of mRSS>20 in the patients who response to omeprazole and partial response to omeprazole. The mRSS was assessed at 17 sites; viz., the face, chest, abdomen, arms, forearms, hands, fingers, thighs, legs and feet. Assessment was rated as 0 (normal skin thickness), 1 (mild but definite skin thickness), 2 (moderate thickness), or 3 (sever thickness with inability to pinch a fold of skin). The score was calculated by summing the rating score from all 17 areas (range, 0-51). mRSS> 20 is defined as yes or no when the patient has mRSS>20 and equal or less than 20, respectively.	4 weeks
The proportion of participant with serum anti-topoisomerase I antibody positive between the patient who response to omeprazole and partial response to omeprazole	The number of anti-topoisomerase I positive in the patients who response to omeprazole and partial response to omeprazole. Serum anti-topoisomerase I antibody is defined as yes or no when the antibody in serum was positive and negative, respectively.	4 weeks

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Collaborators: Thai Rheumatism Association

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: June 7, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Skin Diseases; Gastrointestinal Diseases; Stomach Diseases; Connective Tissue Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Sclerosis; Gastroesophageal Reflux; Esophagitis, Peptic; Scleroderma, Systemic; Scleroderma, Diffuse; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole
• Other Study ID Numbers: PPI partial response GERD SSc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No